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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePARADIGM REAL-TIME INSULIN PUMPS & GUARDIAN REAL-TIME GLUCOSE MONITOR
Classification Namesensor, glucose, invasive
Generic Namecontinuous subcutaneous glucose monitoring system
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS037
Date Received10/22/2008
Decision Date12/16/2008
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software changes made to the guardian real-time glucose monitor (css7100) and paradigm real-time insulin infusion pump (mmt-522, mmt-522k, mmt-722 and mmt-722k).
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